First-in-human Study of a New Treatment (4A10) for Patients With Relapsed or Hard-to-treat Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma, Focused on Safety and How the Drug Behaves in the Body and Early Signs of Effect.
ALT-101
A First in Human, Phase 1, Open-Label Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 4A10 Monotherapy In Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
3 other identifiers
interventional
24
1 country
5
Brief Summary
ALT-101 is a first-in-human Phase 1 clinical trial testing a new antibody drug called 4A10 in patients with relapsed or hard-to-treat acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma. 4A10 is a targeted therapy designed to recognize and attach to a specific protein (CD127) found on leukemia cells. Once it binds, it works in two ways: it blocks growth signals that help cancer cells survive, and it helps the immune system find and destroy those cancer cells. In this study, patients receive 4A10 through an intravenous (IV) infusion once a week. The main goal of the trial is to find out if the drug is safe, what dose can be given, and how the body processes it. Researchers will also look for early signs that the treatment may be working. The study starts with small groups of patients receiving increasing doses to carefully monitor safety. Each patient is closely observed during the first treatment cycle (about 4-6 weeks) to watch for side effects. If the treatment is helping and is well tolerated, patients may continue treatment for up to six cycles. Overall, this study is an early step in testing a new, targeted immune-based therapy for difficult-to-treat blood cancers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2026
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2026
CompletedFirst Posted
Study publicly available on registry
May 14, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
July 28, 2026
July 1, 2026
1.9 years
April 22, 2026
July 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Treatment-Emergent Adverse Events (TEAEs) at each dose level
Assessment of safety and tolerability of 4A10 as measured by the incidence, severity, and relationship of treatment-emergent adverse events, as graded by CTCAE v6, in participants receiving study treatment at each dose-level in the 3+3 dose escalation study design.
Through study duration, an average of 1 year
Determine the Recommended Phase 2 Dose (RP2D)/ Recommended Dose for Expansion (RDE) of 4A10 as a single agent in patients with R/R ALL/LL.
Determination of the RP2D/RDE of ALT-101 based on evaluation of safety, tolerability, and available pharmacokinetic and pharmacodynamic data following dose-escalation.
Through study duration, an average of 1 year
Secondary Outcomes (16)
Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL.
Through study duration, an average of 1 year
Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL.
Through study duration, an average of 1 year
Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL.
Through study duration, an average of 1 year
Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL.
Through the study duration, an average of 1 year.
Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL.
Through the study duration, an average of 1 year
- +11 more secondary outcomes
Study Arms (1)
Single Arm
EXPERIMENTALParticipants receive 4A10 administered by intravenous route according to the protocol-defined dosing schedule in 28-day cycles until disease progression, unacceptable toxicity, withdrawal of consent, or discontinuation per investigator decision.
Interventions
4A10 (Molecule B4532) is an investigational human Immunoglobulin G Subclass 1 (IgG1) monoclonal antibody that specifically binds CD127 (Interleukin-7 receptor alpha subunit, IL-7Rα). CD127 is a component of the interleukin-7 receptor and the thymic stromal lymphopoietin receptor (TSLPR), which are expressed on T-cell acute lymphoblastic leukemia (T-ALL) and pre-B-cell acute lymphoblastic leukemia (B-ALL) cells.
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of T/B-ALL or T/B-LL
- Relapsed or refractory disease without curative options
- Adequate organ function and performance status
You may not qualify if:
- Patients with CNS3 disease
- Patients with DNA fragility syndromes (e.g., Fanconi, Bloom), trisomy 21 (Down Syndrome)
- Prior exposure to anti-CD127 therapies
- Uncontrolled infections
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allterum Therapeutics, Inclead
- National Cancer Institute (NCI)collaborator
- Cancer Prevention Research Institute of Texascollaborator
Study Sites (5)
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Eric Schafer, MD
Baylor College of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2026
First Posted
May 14, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
July 28, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Beginning 6 months after publication of primary results and ending 5 years after publication.
- Access Criteria
- Access available to qualified researchers with a methodologically sound proposal, subject to Sponsor review and execution of a data sharing agreement.
Allterum Therapeutics is committed to responsible sharing of clinical trial data in accordance with the recommendations of the International Committee of Medical Journal Editors (ICMJE), applicable laws and regulations, and protection of participant privacy. Individual participant data (IPD) that underlie the results reported in publications arising from this study, after de-identification, may be made available to qualified researchers upon reasonable request. Supporting documents, including the study protocol, may also be made available, as appropriate. Data will become available beginning 6 months following publication of the primary study results and may remain available for up to 5 years thereafter. Requests for access must include a scientifically sound research proposal and may be subject to review by the Sponsor. Data will be provided only after execution of an appropriate data sharing agreement.